MAUDE Adverse Event Report: MEDTRONIC, INC. PATIENT CABLE; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INC

Model Number 5487L

Device Problems Failure to Capture (1081); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2022

Event Type  malfunction  

Event Description

It was reported that the pacing cable was connected to the lead and was unable to capture, the cable was replaced but the issue was unresolved.The cables were replaced with an alternative model and the lead was then captured.No patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PATIENT CABLE
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INC
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 14468900
• MDR Text Key: 292356173
• Report Number: 2182208-2022-01665
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5487L
• Device Catalogue Number: 5487L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 05/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male